A large number of diagnostic and interventional procedures involve the percutaneous introduction of instrumentation into a vein or artery. For example, coronary angioplasty, angiography, atherectomy, stenting of arteries, and many other procedures often involved accessing the vasculature through a catheter placed in the femoral artery or other blood vessel. Once the procedure is completed and the catheter or other instrumentation is removed, bleeding from the punctured artery must be controlled.
Traditionally, external pressure has been applied to the skin entry site to stem bleeding from a puncture wound in a blood vessel. Pressure is continued until hemostasis has occurred at the puncture site. In some instances, pressure must be applied for up to an hour or more during which time the patient is uncomfortably immobilized. In addition, a risk of hematoma exists since bleeding from the vessel may continue beneath the skin until sufficient clotting effects hemostasis. Further, external pressure to close the vascular puncture site works best when the vessel is close to the skin surface and may be unsuitable amounts of subcutaneous adipose tissue since the skin surface may be a considerable distance from the vascular puncture site.
More recently, devices have been proposed to promote hemostasis directly at a site of a vascular puncture. One class of such puncture sealing devices features an intraluminal anchor which is placed within the blood vessel and seals against an inside surface of the vessel puncture. The intraluminal plug maybe used in combination with a sealing material positioned on the outside of the blood vessel, such as collagen. Sealing devices of this type are disclosed in U.S. Pat. Nos. 4,852,568; 4,890,612; 5,021,059; and 5,061,274. Another approach to subcutaneous blood vessel puncture closure involves the delivery of non-absorbable tissue adhesives, such as cyanoacrylate, to the perforation site. Such a system is disclosed in U.S. Pat. No. 5,383,899.
The use of these conventional devices presents several drawbacks, including: (1) Complex and difficult applications; (2) Partial occlusion of the blood vessel by the anchor when placed properly; and (3) Complete blockage of the blood vessel or a branch of the blood vessel by the anchor if placed improperly.
More recently, sealing methods have been disclosed which use an energy source, such as heat, to seal the puncture. These methods are a significant departure from the well-known pressure- or plug-based methods and can require a practitioner to learn an entirely new procedure using unfamiliar devices.
Accordingly, it would be desirable to provide apparatus that reliably seals vessel puncture openings using methods that are already familiar to the practitioner.